DESCRIPTION: The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. While one of the most prevalent routes of abuse for opioid medicines is the oral route, current formulation- and molecular-based technologies are primarily designed to resist abuse via non-oral routes (e.g., inhalation and injection). Consequently, these approaches fail to adequately address oral abuse and overdose (i.e., co-ingestion of multiple pills), and can be easily thwarted by straightforward extraction techniques. To address the nation's prescription drug misuse, abuse, and overdose epidemics, comprehensive, robust abuse-resistance technologies need to be developed and, ideally, applied to all prescription opioid drugs. To that end, we propose to qualify at least one product candidate for IND-enabling studies from a unique class of proprietary molecules designed to provide effective opioid-based pain relief, with unprecedented protection from all routes of abuse. We are applying for Fast-Track because NIDA program officials assured us that our proposed project is an excellent Fast-Track candidate based on: Compelling in vitro and in vivo data from studies led by our Principal Investigator demonstrate feasibility; Current formulation-based technologies do not effectively address oral misuse, abuse, and overdose; and Key stakeholders (i.e., potential large pharmaceutical partners - for development and commercialization, key opinion leaders, prescribing physicians, and patients) have expressed strong interest in our technology.